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Jessica Palacio, False Statement to Investigator, Florida 2022

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Florida Woman Sentenced to Prison for False Statement to Investigator

A federal judge has sentenced a Florida woman to prison for making a false statement to a government investigator related to a clinical trial that studied the effectiveness of asthma drugs in children.

Jessica Palacio, 37, of Miami, was convicted by a jury on September 13, 2022, for lying to a U.S. Food and Drug Administration (FDA) investigator during a 2017 regulatory inspection of the firm conducting the drug trial.

According to evidence presented at trial, Palacio worked from 2013 to 2015 as a clinical research coordinator at a clinical trial firm in Miami called Unlimited Medical Research (UMR). UMR was one of many companies hired to conduct a clinical trial designed to investigate the safety of an asthma medication in children.

The drug manufacturer identified issues in the trial performed by the company based on a review of data and notified the FDA.

In May 2021, a grand jury in Miami returned a two-count indictment against Palacio alleging a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to UMR, received physical exams from a clinical investigator, and took study drugs as required, when in fact these events had not occurred.

Judge Darrin P. Gayles sentenced Palacio to 36 months in prison and three years of supervised release on January 12.

The FDA Office of Criminal Investigations investigated the case, and Senior Litigation Counsel David A. Frank and Trial Attorney Marilee L. Miller from the Civil Division’s Consumer Protection Branch prosecuted the case with the assistance of Associate Chief Kyrsten Melander for Enforcement at FDA’s Office of Chief Counsel.

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